Response to INsurance companies
Hello: I was asked for a response to insurers who deny vascepa here it is. Denial will be based on one of two suppositions -
a.) Substitution of substandard treatment
b.) Belief that trigs in the 200- 500mg / dl range need not be treated
this letter covers both - feel free to copy and use
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I am writing to request the medication Vascepa for patient …... .
You have either denied the treatment of offered substitution of niacin, fenofibrate, lovaza or over-the-counter FISH OIL
1.) Offer of Substitution:
If you have offered a substitute for Vascepa then you have automatically negated the FDA supposition that trigs in the 200- 500 mg/dl range need not be treated . Therefore the question becomes which medication is best for this issue:
a.) Niacin
Outcomes studies with Niacin reveled it to be useless to lower CAD associated with elevated Triglycerides. Do you really want me to prescribe a medication that was shown to be useless ?
b.) Fenofibrates
With respect to fenofibrates :
1. Myopathy and rhabdomyolysis have been reported in patients taking fenofibrate. This risk is increased when taken in combination with a statin
2. Tricor can increase serum transaminase. Requiring Monitor liver tests, ALT periodically
3. Tricor can reversibly increase serum creatanine levels. Monitor renal function with renal impairment
4. Fenofibrates have mixed outcomes studies
a. FIELD STUDY
Fenofibrate did not significantly reduce the risk of the primary outcome of coronary events. It did reduce total cardiovascular events, mainly due to fewer NFMI and revascularizations.
Do you really want me to prescribe a medication that has this many side effects when it is unkown whether it works or not ?
c.) Lovaza
Lovaza increases the highly atherogenic particle LDL by 49%.! You cant seriously expect me to substitute Lovaza to reduce triglyceride in the hopes of reducing CAD when it increases LDL by 49% - it may very well be inducing the very disease I am trying to prevent
d.) OTC Fish Oil
To match the efficacy of Vascepa the patient would have to take over 18 capsules of otc fish oil per day – do you really seriously want them to do that ? Also OTC fish oil may be both DHA and EPA. DHA has been shown to elevated LDL significantly thereby actually inducing the very disease we are trying to prevent.
EPA (Vascepa) the medication I have chosen has an outcomes study in Japan – JELIS which revealed 50% reduction in CAD. Vascepa has almost no side effects
In summary , (ins company ) agrees contrary to FDA findings that trigs in the 200 – 500 range should be treated. The medications they offer either have no outcomes studies or negative outcomes studies and have very serious side effects. The medication I have chosen has positive outcome studies and no side effects. I therefore ask to allow vascepa utilization for those patients with trigs in the 200- 500 range giving them the best medication in this class .
2.) Coverage of Vascepa decline based on the highly controversial belief that TRIG in the 200- 500 mg/ dl need not be treated
Newest guidelines (ATP IV) have simply ignored the triglyceride issue. They have neither said treat or do not treat. Since triglycerides were not addressed it is entirely logical to continue with the existing standard – ie if there is no change this DOES NOT mean cease treating – It means no changes are warranted.
You are well aware that recently , NEJM published groundbreaking studies showing an almost definitive link between high triglycerides and extremely high risk of heart attacks (study showed 40pct reduction in heart attacks for those w normal triglycerides versus high levels.) This clearly reveals the need to treat triglyceride elevations . In addition, you are well aware of the JELIS study involving 18,000 individuals in Japan that showed almost a 50% reduction on coronary events for individuals already taking statin to which EPA (Vascepa) was added . There are a plethora of studies revealing EPA’s benefits in lowering inflammatory markers associated with CAD. Most recently The Journal of Cardiology published research that revealed pre-treatment with EPA in addition to statins significantly reduced the incidence of type IVa MI compared to statin therapy only.
Therefore, in either situation – offer of substitution or denial of treatment for trigs in the 200- 500 mg/dl range you are offering your customer substandard treatment. If you prevent your customer access to Vascepa you are potential contributing to the development of CAD and their early demise. All substitutions are of substandard efficacy and lack of treatment is contrary to the existing mounting scientific evidence. Your failure to cover this medication will require me, as my patients advocate, to ask for a State Insurance Commissioner investigation of such
Sincerely,
